Therapeutic EquivalencyPhase 1NCT01359163
A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
A Phase 1 study testing etynodiol diacetate in people with Therapeutic Equivalency, run by Pfizer at 1 site in Singapore.
Trial summary
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- etynodiol diacetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.
- Conditions
- Therapeutic Equivalency
- Being tested
- etynodiol diacetate
- Keywords
- bioequivalence study, marketed vs reformulation tablets, Femulen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etynodiol diacetateDrug
tablet, 0.5 mg, single dose
etynodiol diacetateDrug
tablet, 0.5 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Femulen commercial tablets | Active comparator | Not described Receives: Drug: etynodiol diacetate |
| Femulen reformulated tablets | Experimental | Not described Receives: Drug: etynodiol diacetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve to last time point observed (AUCt)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Highest concentration (Cmax)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Secondary outcomes (4)
Area under the curve to infinity (AUCinf)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Area under the curve percent to infinity (AUC%inf)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Half-life (T1/2)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Time at maximum concentration (Tmax)
Measured: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359163
- Sponsor's protocol ID
- B1361002
- Status last verified
- Apr 2012
- First submitted
- 20 May 2011
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01359163
- Acronym / sponsor ID
- B1361002
- Conditions
- Therapeutic Equivalency
- Keywords
- bioequivalence study, marketed vs reformulation tablets, Femulen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femulen commercial tablets | Active comparator | Drug: etynodiol diacetate |
| Femulen reformulated tablets | Experimental | Drug: etynodiol diacetate |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etynodiol diacetatetablet, 0.5 mg, single dose | Drug | Femulen commercial tablets |
| etynodiol diacetatetablet, 0.5 mg, single dose | Drug | Femulen reformulated tablets |
Primary outcome
Area under the curve to last time point observed (AUCt)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Highest concentration (Cmax)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
4 secondary outcomes
Area under the curve to infinity (AUCinf)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Area under the curve percent to infinity (AUC%inf)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Half-life (T1/2)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Time at maximum concentration (Tmax)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing etynodiol diacetate in people with Therapeutic Equivalency, run by Pfizer at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve to last time point observed (AUCt) (time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.